Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome
NCT07456787 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78
Last updated 2026-03-06
Summary
The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery.
Analysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.
Analysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12.
These questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.
To evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels.
To assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.
Conditions
- Total Knee Arthroplasty\(TKA\)
- Osteoartrosi
Interventions
- DEVICE
-
Cryopressotherapy
Comparison between Cryopressotherapy and ice pack in patients undergoing Total Knee Arthroplasty to improve clinical outcomes
- DEVICE
-
Ice pack
Comparison between ice pack and cryopressotherapy
Sponsors & Collaborators
-
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
lead OTHER
Principal Investigators
-
Laura Mangiavini · University of Milan, IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-29
- Primary Completion
- 2025-10-13
- Completion
- 2028-02-29
Countries
- Italy
Study Locations
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